Abstract
Background
The real-world efficacy, feasibility, and prognostic factors of immune-checkpoint inhibitor combination therapy for unresectable or metastatic esophageal cancer are not fully established.
Methods
This multi-institutional retrospective cohort study evaluated 71 consecutive patients treated with immune-checkpoint inhibitor combination therapy for esophageal cancer between March 2021 and December 2022. We assessed tumor response, safety, and long-term survival.
Results
In patients with measurable lesions, the response rate was 58%, and the disease control rate for all enrolled patients was 80%. Five patients (7.0%) underwent successful conversion surgery. Grade 3 or higher immune-related adverse events occurred in 13% of patients, and one patient (1.4%) died due to cholangitis. Median progression-free survival was 9.7 (95% confidence interval: 6.5–not reached). C-reactive protein levels and performance status were identified as significant predictors of progression-free survival through Cox proportional hazards analysis.
Conclusions
Immune-checkpoint inhibitor combination therapy for esophageal cancer demonstrated comparable tumor response, safety, and long-term survival to previous randomized clinical trials. Patients with good performance status and low C-reactive protein levels may be suitable candidates for this treatment.
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Data availability
The evaluation data set analyzed in the current study is not available publicly. However, the data are available from the corresponding author on request.
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Acknowledgements
This study was supported by investigators at 8 hospitals (Toho University Omori Medical Center, Jichi Medical University Hospital, Fukushima medical University, Jikei University Hospital, Yokohama City University Hospital, Teikyo University School of Medicine, Yokohama City University Medical Center,). We thank all investigators at these institutions.
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Author S.S and H.S contributed to the study conception, design, data analysis, and interpretation. Data collection was performed by author T.S, T.C, S.H, Y.S, Z.S, K.T, T.K, and Y.M. The first draft of the manuscript was written by author S.S and H.S. All authors commented on previous versions of the manuscript and approved the final manuscript.
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Authors S.S, T.K, K.K, H.Y, H.S, Y.M, Y.I, Y.S, S.H, and H.S received lecture fee from Ono pharmaceutical co., ltd. Authors S.S and S.H received lecture fee from Bristol Myers Squibb co. Authors S.S, K.K, H.Y, and H.S received lecture fee from Taiho pharmaceutical co. ltd. Authors S.S, K.K, H.Y, H.S, Y.M, S.H, and H.S received lecture fee from MSD co. ltd. Authors S.S and K.K received lecture fee from DAIICHI SANKYO co. ltd. Authors K.K and H.Y received lecture fee from Chugai pharmaceutical co. Authors Y.I, H.Y, and K.K received lecture fee from Takeda pharmaceutical co., ltd. Author H.Y received lecture fee from Yakult Honsha co., ltd. Authors I.E and H.S received research grant from Ono pharmaceutical co., ltd. Authors H.Y, C.K, and H.S received research grant from Taiho pharmaceutical co. ltd. Authors H.Y, C.K, I.E, and Y.I received research grant from Chugai pharmaceutical co. Authors Y.S and C.K received research grant from Yakult Honsha co., ltd. Author Y.I received research grant from Takeda pharmaceutical co. ltd and Shionogi pharmaceutical co. ltd. Author I.E received research grant from Asahi Kasei Pharma corporation.
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Sato, S., Ssuzuki, T., Chinen, T. et al. The real-world data of immune-checkpoint inhibitor combination therapy for unresectable or metastatic esophageal cancer: a multi-institutional cohort study. Int J Clin Oncol (2024). https://doi.org/10.1007/s10147-024-02532-0
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DOI: https://doi.org/10.1007/s10147-024-02532-0